Systems and methods employing a push tube for delivering a urethral sling

ABSTRACT

Systems, methods, and devices employing a push tube to deliver an implant are disclosed.

CROSS REFERENCE TO RELATED APPLICATIONS

This application claims the benefit of and priority to U.S. ProvisionalPatent Application Ser. No. 60/569,300 filed on May 6, 2004, which ishereby incorporated by reference in its entirety.

FIELD OF THE INVENTION

The invention generally relates to systems and methods for delivering animplantable sling to an anatomical location in a patient. In variousembodiments, the invention is directed to systems and methods relatingto the use of a push tube during sling delivery.

BACKGROUND OF THE INVENTION

Anatomical tissues may become weakened or damaged by age, injury, ordisease. This decrease in the structural integrity of anatomical tissuesmay have significant medical consequences. Even in the absence of tissuenecrosis, weakening of an anatomical structure may impair one or more ofthe biological functions of the tissue. To help alleviate this impact onbiological function, implantable, supportive slings have been developed.These slings can be implanted into a patient to provide support for theweakened or damaged tissue. The support provided by the sling mimics thenatural position and structure of the tissue, and thereby helps decreaseor eliminate impairment of biological function resulting from tissueweakening or damage. Although supportive slings have been used innumerous contexts to address the weakening of a variety of anatomicaltissues, they have proven particularly useful for decreasing urinaryincontinence resulting from weakening or damage to urethral,periurethral and/or bladder tissue.

Stress urinary incontinence (SUI) affects primarily women, but also men,and is generally caused by two conditions, intrinsic sphincterdeficiency (ISD) and hypermobility. These conditions may occurindependently or in combination. In ISD, the urinary sphincter valve,located within the urethra, fails to close properly (coapt), causingurine to leak out of the urethra during stressful activity.Hypermobility is a condition in which the pelvis floor is distended,weakened, or damaged, causing the bladder neck and proximal urethra torotate and descend in response to increases in intra-abdominal pressure(e.g., due to sneezing, coughing, straining, etc.). As a result, thepatient's response time becomes insufficient to promote urethral closureand, consequently, the patient suffers from urine leakage and/or flow.SUI has a variety of causes including, but not limited to, pregnancy,aging, infection, injury, congenital defect, and disease.

A popular treatment of SUI involves placement of implantable slingsunder the bladder neck or the mid-urethra to provide a urethralplatform. Placement of the sling limits the endopelvis fascia drop.There are various methods for placing the sling. Slings can be affixedand stabilized using traditional bone anchoring approaches, as well asrecently developed anchor-less methods. Additionally, a variety ofimplantation procedures, including various routes of administration,exist. These procedures provide physicians with a range of implantationoptions. Physicians can readily select amongst the various implantationprocedures based on numerous patient-specific factors including, but notlimited to, age, gender, overall health, location of tissue defect, thedegree of tissue impairment, and the like. Furthermore, physicians canselect from amongst numerous sling delivery devices that facilitatesling placement.

Despite the numerous advances in sling design, implantationmethodologies, and delivery devices, no single method and/or device isappropriate for every situation. Accordingly, devices, systems, andmethods that offer new approaches for sling implantation would beadvantageous to the medical community.

SUMMARY OF THE INVENTION

The invention addresses deficiencies of the prior art by providingdevices, systems and methods for facilitating delivery of an implant toan anatomical site. According to a preferred embodiment, the device canbe used to deliver an implant, such as a sling for treating urinaryincontinence, to a mid-urethral location of a patient. The methods andsystems of the invention simplify the delivery of the implant by using adelivery system including a push tube.

In one aspect, the invention provides a sling delivery system comprisinga sling assembly including an implantable sling, sized and shaped forproviding a urethral platform. The sling assembly may also include asleeve for covering, at least partially, the sling. In preferredembodiments, the sling is free floating inside the sleeve and does notattach to the sleeve or anything else. The sleeve may have a gapexposing a portion of the sling. The sleeve includes a looped portion,covered at least partially by a tab, extending out of the plane of thesleeve and the sling. In some embodiments, the tab prevents the sleevefrom being removed from the sling, and cutting the tab permits sleeveremoval. The sling assembly also includes first and second dilatortubes, possessing longitudinally extending through lumens and located atfirst and second ends of the sling assembly. In some embodiments, thedilator tubes attach to ends of the sleeve. In other embodiments, thedilator tubes also or alternatively attach to ends of the sling.

In preferred embodiments, the sling delivery system includes one or morepush tubes for slidably interfitting within the dilator tubes of thesling assembly. The push tube includes a shoulder or flared end wherethe external diameter of the push tube is substantially greater than theremaining portion of the push tube. The shoulder is sized and shaped toprevent its passage through the lumen of the dilator tube and may belocated at an end or intermediate location of the push tube. In someembodiments, the shoulder may abut an end of the dilator tube. The pushtube may have a uniform or variable diameter and may include a taperedtip. The push tube also includes a longitudinally extending throughlumen, which runs the length of the push tube.

According to some aspects, the sling delivery system includes a deliverydevice including a shaft attached to a handle. The shaft of the deliverydevice is sized and shaped to slidably fit within the lumen of the pushtube. Similarly, the lumen of the push tube is sized and shaped forslidably interfitting over the shaft of the delivery device. Accordingto one feature, this configuration enables the push tube to rotatefreely about the shaft and enables the dilator tube to rotate freelyabout the push tube. Such rotation reduces twisting or other deformationof the sling and sling/sleeve combination during sling placement. Theshaft of the delivery device may be inserted into the lumen of the pushtube from either end of the push tube. The shaft and the handle of thedelivery device may be substantially in the same plane or in differentplanes, and the shaft may include sections located in different panes.One or more parts or the shaft may assume a curved, angled, halo,helical, or any other suitable shape including substantially straight.The shaft includes a distal tip that may be conical in shape and mayhave a sharp or blunt end. The tip may be designed for percutaneouspunctuation and/or advancement through tissue of a patient.

According to a feature of the invention, the delivery device of thesling delivery system includes an optional pusher mechanism, whichslidably interfits onto the shaft of the delivery device such that thepusher mechanism can freely slide over any portion of the shaft. Thepusher mechanism includes a grasping area for grasping by a medicaloperator and a distal surface for abutting an end of the push tube. Amedical operator can advance the pusher mechanism distally along theshaft of the delivery device to facilitate sliding of the push tube offthe shaft

In some embodiments, the push tube includes a window section where aportion of the push tube wall is removed, absent, or cut out, thusexposing the lumen. The window section, which is intermediate to theends of the push tube, facilitates sliding of the shaft within the lumenof the push tube.

In another embodiment of the invention, the push tube includes two endportions, located near ends of the push tube, and an intermediateportion, which is smaller in outer diameter than the end portions and islocated at an intermediate position between the end portions. Theintermediate portion is sized and shaped to slidably move through thelumen of the dilator tube. Shoulders, formed by the transitions betweenthe end portions and the intermediate portion, can abut an interior endand an exterior end of the dilator tube, trapping the dilator tubebetween the shoulders of the push tube.

According to one aspect, the invention provides a method for treatingurinary incontinence comprising implanting a surgical sling into thebody of a patient via a vaginal cavity, comprising the steps ofinserting a shaft of a delivery device transabdominally through thevaginal wall of a patient, slidably interfitting a push tube onto an endof the shaft extending through the vaginal wall, and removing the shaftfrom the patient to implant a portion of the sling in the periurethraltissue in the body of the patient. In some embodiments, the methodincludes the step of sliding the push tube along the shaft until itextends through an abdominal incision prior to removing the shaft. Themethod may also include the step of grasping the push tube where itextends through the abdominal incision prior to removing the shaft.According to a further embodiment, the steps of the method may berepeated with a second push tube.

According to another aspect, the invention provides a method fortreating urinary incontinence comprising implanting a surgical slinginto the body of a patient via a vaginal cavity, comprising the steps ofslidably interfitting a push tube onto an end of a shaft of a deliverydevice, inserting the shaft transvaginally through the vaginal wall of apatient, and removing the shaft from the patient to implant a portion ofthe sling in the periurethral tissue in the body of the patient. In someembodiments, the method includes the step of sliding the push tube alongthe shaft until it extends through an abdominal incision prior toremoving the shaft. The method may also include the step of grasping thepush tube where it extends through the abdominal incision prior toremoving the shaft. In some embodiments, the step of sliding the pushtube is actuated by a pusher mechanism. According to a furtherembodiment, the steps of the method may be repeated with a second pushtube.

According to a feature of the invention, the sling delivery systems anddevices of the invention may be sized and shaped for abdominal,transvaginal, or transobtural procedures. Additionally, the methods ofthe invention may include positioning at least one of a first end and asecond end of a sling and/or sling assembly in front of the pubic bone,behind the pubic bone, near the pubic bone, and/or near or through anobturator foramen.

Other aspects and advantages of the invention are described below.

BRIEF DESCRIPTION OF THE DRAWINGS

The following figures depict illustrative embodiments of the inventionin which like reference numerals refer to like elements. These depictedembodiments may not be drawn to scale and are to be understood asillustrative of the invention and not as limiting in any way.

FIGS. 1A-1B depict perspective and side views, respectively, of a slingassembly according to an illustrative embodiment of the invention.

FIG. 2 depicts a sling delivery system employing the sling assembly ofFIG. 1.

FIG. 3 depicts the sling delivery system of FIG. 2 assembled forimplanting a sling via a transabdominal implant method.

FIGS. 4A-F depict a method for introducing a sling via a transabdominalimplantation method according to an illustrative embodiment of theinvention.

FIG. 5A-E depict a method for introducing a sling via a transvaginalimplantation method according to an illustrative embodiment of theinvention.

FIG. 6 depicts a sling delivery system employing the sling assembly ofFIG. 1 and an alternative push tube according to another illustrativeembodiment of the invention.

FIG. 7 depicts a sling delivery system similar to that of FIG. 6assembled for introducing a sling via a transvaginal implantation methodaccording to another illustrative embodiment of the invention.

FIGS. 8A-D depict a method for introducing a sling via a transvaginalimplantation method according to an illustrative embodiment of theinvention.

FIG. 9 depicts a sling delivery system employing a push tube with anaxially extending cut out according to an illustrative embodiment of theinvention.

FIG. 10 depicts a sling delivery system employing the sling assembly ofFIG. 1 and an alternative push tube according to another illustrativeembodiment of the invention.

ILLUSTRATIVE DESCRIPTION

As described above in summary, the invention in various illustrativeembodiments is directed to systems, devices, and methods employing apush tube to deliver a sling to the periurethral tissues of a patient.

FIG. 1A shows a front perspective view of a sling assembly 100 of thetype employed with a push tube of the invention. As shown, the slingassembly 100 has first 100 a and second 100 b ends. The sling assembly100 includes a sling 102 and a sleeve 104 for covering, at leastpartially, the sling 102. The sling 102 is free floating inside thesleeve 104. The sleeve 104 has first 104 a and second 104 b portions.The sleeve 104 also includes first and second end portions 105 a and 105b, respectively. The sling assembly 100 also includes first 107 andsecond 108 dilator tubes. The tubes 107 and 108 have exterior ends 107 aand 108 a, respectively, as well as interior ends 107 b and 108 b,respectively. The tubes 107 and 108 also have longitudinally extendingthrough lumens 106 a and 106 b, respectively. The sling 102 and thesleeve 104 are further described below.

FIG. 1B shows a side view of the sling assembly 100. The sleeve portion105 a wraps partially around and attaches to the dilator tube 107.Attachment may be by any suitable mechanism, including, withoutlimitation, heat bonding, gluing, stapling, stitching, shrink wrappingor the like. The sleeve portion 105 b attaches to the dilator tube 108in a similar fashion. In other illustrative embodiments, the sling endportions 102 a and 102 b may attach to the dilator tubes 107 and 108,respectively, in a similar fashion. Alternatively, the dilator tubes 107and 108 may be directly attached to the ends of the sling 102 a and 102b.

The longitudinally extending through lumens 106 a and 106 b run thelength of dilator tubes 107 and 108, respectively. In some embodiments,the lumens 106 a and 106 b have a uniform diameter. In otherembodiments, the lumens 106 a and 106 b have one or more locations ofincreased and/or decreased diameter. For example, the dilator tubewalls, which define the lumens 106 a and 106 b, may have bumps, ridges,shoulders, grooves, or other internal protuberances, which may increaseor decrease the size of the lumens 106 a and 106 b.

As shown in FIG. 1B, an opening or gap 110 is located near a midpoint ofa top surface 104 c of the sleeve 104. The gap 110 exposes a portion 102c of the sling 102 where the entire width of the sling 102 is exposed.In other embodiments, the sleeve 104 covers the sling 102 completely.Additionally, in some embodiments, there may more than one gap along thelength of the sleeve 104 where the sling 102 is not covered by thesleeve 104.

According to the illustrative embodiment, the sleeve portions 104 a and104 b are formed as an integral sleeve 104 having a continuous bottomside 104 d. The bottom side 104 d includes a looped portion 104 e. Thelooped portion 104 e of the sleeve 104 extends downward out of the planeof the sleeve portions 104 a and 104 b and the sling 102, for example,at an angle of about 90 degrees. The looped portion 104 e is covered bya tab 112, which fits over the looped portion 104 e. In otherembodiments, the sleeve portions 104 a and 104 b may be separatesections fastened to each other on the bottom side 104 d by way of afastener or the tab 112.

Although the looped portion 104 e and the gap 110 are shown at themid-point of the sleeve 104, in other illustrative embodiments, thelooped portion 104 e and the gap 110 may be near the mid-point of sleeve104, but not at the mid-point, or even substantially off set from themid point.

The tab 112 can be used during implantation as a visual aid forplacement of the sling 102. According to the illustrative embodiment,the tab 112 also inhibits, or in some embodiments, prohibits the sleeve104 from sliding off, or otherwise being removed from, the sling 102during sling assembly placement. Preferably, the tab 112 must be cut toenable the sleeve 104 to slide off the sling 102. According to oneembodiment, cutting the tab 112 enables the sleeve portions 104 a and104 b to be slid off the sling ends 102 a and 102 b, respectively. Thisfeature ensures that the sleeve 104 cannot be removed simply by applyinga pulling force, for example, on the sleeve end sections 105 a and 105 bor on the tab 112. Such a force may be applied to the sling assemblyends by a medical operator during sling assembly placement.

During placement, after the sling assembly 100 is positioned within thepatient, a cut is made through the center of the tab 112, and thusthrough the looped portion 104 e of the sleeve 104, allowing the twosleeve portions 104 a and 104 b to be separated from each other. Thesleeve portions 104 a and 104 b are then slid off of the sling 102, outof the body of the patient by pulling on the two sleeve portions 104 aand 104 b, the sleeve end portions 105 a and 105 b, the two dilatortubes 107 and 108, or generally on the two ends 100 a and 100 b of thesling assembly 100. A more detailed description of the tab 112 and othermechanisms of fastening the sleeve portions 104 a and 104 b are providedin the co-pending U.S. patent application Ser. No. 10/642,395 entitled“Systems, Methods and Devices Relating to Delivery of Medical Implants,”the entire disclosure of which is incorporated by reference herein.

The sleeve 104 may be made, for example, from one or more absorbentmaterials, such as a sponge-like material, which can optionally bepre-soaked in a drug solution, for example, in an anesthetic,anti-inflammatory, coagulating, anticoagulating, and/or antibioticsolution. In other embodiments, the sleeve 104 may be made from anon-wettable material, such as polypropylene, polyethylene, polyester,polytetrafluoroethylene (available from DuPont Corporation, Wilmington,Del., under the trademark TEFLON®), TYVEK®, MYLAR®, or co-polymersthereof. The non-wettable materials can also be pretreated with atherapeutically effective drug treatment. The sleeve 104 is preferablytransparent so that an operator can to see the sling 102 inside thesleeve 104. In some embodiments, the sling 102 and/or sleeve 104 may becolored to facilitate placement of the sling by the operator. The sleeve104 may include both transparent and colored sections.

According to the illustrative embodiment, the sling 102 is from about 1to 3 cm in width and from about 10 to 45 cm in length, and terminates atfree ends. The sling 102 is shown to be rectangular, but it may haveanother suitable shape. The sling 102 may have a uniform thickness overits entire length and/or width. Alternatively, the thickness can besuitably varied at one or more locations. According to the illustrativeembodiment, the thickness of the sling 102 material ranges from about0.02 to about 0.10 cm.

According to the illustrative embodiment, the length of the sling 102 isshorter than the length of the sleeve 104, and the sling 102, includingboth ends 102 a and 102 b, does not connect to the sleeve 104 oranything else. During sling assembly placement, this feature enables amedical operator to pull on the sling assembly ends 100 a and 100 b, forexample, via the dilator tubes 107 and 108, and/or any of the deliverydevices to be used for placement, without risk of stretching, curling orotherwise deforming the sling 102.

In the illustrative embodiment, the sling 102 is made entirely ofpolypropylene. However, sling 102 may be fabricated from any of a numberof biocompatible materials, such as nylon, polyethylene, polyester,polypropylene, fluoropolymers, copolymers thereof, combinations thereof,or other suitable synthetic material(s). The material may be, forexample, a synthetic material that is absorbable by the patient's body,such as polyglycolic acid, polylactic acid, and other suitableabsorbable synthetic materials. Alternatively, the material for thesling 102 may be derived from mammalian tissue(s) or a combination ofmammalian tissue(s) and synthetic material(s). The sling material may befabricated from one or more yarns, which yarns may be made from one ormore materials. The sling 102 may incorporate or be coated with one ormore agents to provide a therapeutic effect, for example, to reducediscomfort, to reduce the chance of infection and/or to promote tissuegrowth.

As mentioned above, in one exemplary embodiment, the length of the sling102 is shorter than the length of the sleeve 104, and the sling 102 doesnot connect to the sleeve 104 or anything else. This feature inhibitsthe medical operator from gripping the free ends of the sling 102 andinadvertently tensioning the sling 102. This feature may be furtherenhanced by making the sling 102 long enough to support the urethra, butnot long enough to expose the ends 102 a and 102 b of the sling outsidethe body. This has the advantage of preventing infection caused by theexposure of the sling 102 external to the body. By way of example, anillustrative sleeve 104 may be about 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm,7 cm, 8 cm, 9 cm, or 10 cm longer than the sling 102. According to otherillustrative embodiments, the sleeve 104 may be about 10 cm, 15 cm, 20cm, 25 cm, or 30 cm longer than the sling 102. In particular, intransobtural procedures, the sling 102 may be configured to be longenough to extend to, or through, both obturator foramen, but not longenough to extend outside of the body. In other embodiments, the sling102 may be configured in length to extend outside of the body, whenplaced, and the ends then trimmed to length by the physician to a pointjust under the skin.

In one illustrative embodiment, the edge regions of the sling 102 can beconfigured differently depending on their intended placement in the bodyof the patient. For example, a midsection of the sling is typicallylocated where an anatomical site, such as a mid-urethral or bladder necklocation in the periurethral tissue, needs to be supported. In oneillustrative embodiment, the midsection of the sling 102 has smooth orrounded edges, hereinafter also referred to as “non-tanged” or“de-tanged.” According to a further illustrative embodiment, othersections of the sling may include tangs (e.g., sharp projections orfrayed edges). The tangs are generally useful for anchoring the sling102 and/or encouraging tissue growth into the sling. Anchoring the sling102 in this manner generally obviates the need for additional sutures tohold the sling in place.

The tanged and non-tanged edges of the sling 102 can be formed in aplurality of ways. For example, the sling 102 can be cut from a wovensheet, in which case the edges would be initially tanged along theentire length of the sling. One or more non-tanged sections may beformed by any process that smoothes, rounds or removes the sharp edgesof the tangs. For example, the tangs may be heat-smoothed by burning ormelting the tangs. In one embodiment, the non-tanged section has alength of about 1 to about 5 cm, preferably about 2 to about 2.5 cm, oneither or both sides of the center line of the sling. Providing one ormore non-tanged sections, which may be in close proximity to a sensitiveanatomical site in the patient, can enhance the comfort level of thepatient and reduce the potential for the edges of the tangs to erode orirritate the urethra. Alternatively, the sling 102 can be produced froma woven tape having the approximate finished width of the sling. Thesmooth sides of the tape can then be trimmed off to produce the tangedsections.

Without limitation, any suitable sling assembly 100 may be employed withthe invention. Examples of slings, sling assemblies, delivery devicesand implantation approaches with features that may be employed in thepresent invention are disclosed in U.S. Pat. No. 6,666,817, entitled“Expandable surgical implants and methods of using them,” U.S. Pat. No.6,669,706, entitled “Thin soft tissue surgical support mesh,” U.S. Pat.No. 6,375,662, entitled “Thin soft tissue surgical support mesh,” U.S.Pat. No. 6,042,592, entitled “Thin soft tissue surgical support mesh,”U.S. Pat. No. 6,752,814, entitled “Devices for minimally invasive pelvicsurgery,” U.S. patent application Ser. No. 10/774,826, entitled “Devicesfor minimally invasive pelvic surgery,” U.S. patent application Ser. No.10/093,398, entitled “System for implanting an implant and methodthereof,” U.S. Pat. No. 7,025,772, entitled “System for implanting animplant and method thereof,” U.S. Pat. No. 6,991,597, entitled “Systemfor implanting an implant and method thereof,” U.S. Pat. No. 6,936,052,entitled “System for implanting an implant and method thereof,” U.S.patent application Ser. No. 10/093,450, entitled “System for implantingan implant and method thereof,” U.S. Pat. No. 7,235,043, entitled“System for implanting an implant and method thereof,” U.S. patentapplication Ser. No. 10/631,364, entitled “Bioabsorbable casing forsurgical sling assembly,” U.S. patent application Ser. No. 10/641,376,entitled “Spacer for sling delivery system,” U.S. patent applicationSer. No. 10/641,487, entitled “Systems, methods and devices relating todelivery of medical implants,” U.S. patent application Ser. No.10/642,395, entitled “Systems, methods and devices relating to deliveryof medical implants,” U.S. patent application Ser. No. 10/642,397,entitled “Systems, methods and devices relating to delivery of medicalimplants,” U.S. patent application Ser. No. 10/832,653, entitled“Systems and methods for sling delivery and placement,” U.S. patentapplication Ser. No. 10/939,191, entitled “Devices for minimallyinvasive pelvic surgery,” U.S. Provisional Patent Application Ser. No.60/508,600, filed on Oct. 3, 2003 and U.S. Provisional PatentApplication Ser. No. 60/569,300, filed on May 6, 2004, and U.S. patentapplication Ser. No. 10/957,926, entitled “Systems and methods fordelivering a medical implant to an anatomical location in a patient,”filed on Oct. 4, 2004, the entire contents of all of which areincorporated herein by reference.

FIG. 2 shows a perspective view of sling delivery system 200. The system200 includes a sling assembly 100, a push tube 202, and a deliverydevice 208. The push tube 202 contains a first end 202 a and a secondend 202 b. The push tube 202 includes a shoulder or flared end 204located at second end 202 b where the external diameter of the push tubeis substantially greater than the remaining portion of the push tube.The push tube 202 also includes a longitudinally extending through lumen206, which runs the length of the push tube between the first 202 a andthe second 202 b ends. The delivery device 208 includes a handle 210 anda shaft 212.

The push tube 202 is sized and shaped to slidably interfit within thelumen 106 a the dilator tube 107. The push tube 202 may have a uniformdiameter or it may gradually increase or decrease in outside diameterone or more times to provide, for example, bumps, ridges, and/orgrooves, etc. The push tube 202 may be made from materials similar tothose used to make the sling 102 or the sleeve 104. For example, thepush tube 202 may be made from any of a number of biocompatiblematerials, such as nylon, polyethylene, polyester, polypropylene,fluoropolymers, copolymers thereof, combinations thereof, or othersuitable synthetic material(s). The push tube 202 may incorporate or becoated with one or more agents to provide a therapeutic effect, forexample, to reduce discomfort, to reduce the chance of infection and/orto promote tissue growth.

The shoulder 204 is sized and shaped to prevent passage of the shoulder204 through the lumen 106 a of the dilator tube 107, i.e. the shoulder204 extends radially beyond the diameter of the lumen 106 a. The pushtube 202 also includes a longitudinally extending through lumen 206. Insome embodiments, the lumen 206 has a uniform diameter. In otherembodiments, the lumen 206 has one or more locations of increased and/ordecreased diameter. For example, the push tube walls, which define thelumen 206, may have bumps, ridges, shoulders, grooves, or internalprotuberances, which may increase or decrease the size of the lumen 206.The push tube 202 also includes a tip 202 c, which is tapered and/or ofdecreased outer diameter relative to the rest of the push tube 202. Forexample, the tip 202 c may be conical in shape.

The shaft 212 may be, for example, any suitable needle, cannula, tubularmember, tunneler, dilator or the like. In the illustrative embodiment,the shaft 212 is attached to the handle 210 at a proximal end 212 a andcontains a first substantially straight portion 212 b. The proximal end212 a permanently affixes to the handle 210, and the first straightportion 212 b extends distally from the first end 212 a to a curvedportion 212 c. The curved portion 212 c extends distally from the firstend 212 a to a second substantially straight portion 212 d. The secondstraight portion 212 d extends distally from the first end 212 a andterminates at a distal tip 212 e. The distal tip 212 e may be conical inshape and may have a sharp or blunt end. A blunt end provides someresistance to unintended penetration through tissue or organ, such asthe bladder. The tip 212 e may be designed for percutaneous punctuationand/or advancement through tissue of a patient.

The shaft 212 of the delivery device 208 is sized and shaped to fitwithin the lumen 206 of the push tube 202. Similarly, the lumen 206 ofthe push tube 202 is sized and shaped for slidably interfitting over theshaft 212 of the delivery device 208. According to one feature, thisconfiguration enables the push tube 202 to rotate freely about the shaft212 and enables the dilator tube 107 to rotate freely about the pushtube 202. Such rotation reduces twisting or other deformation of thesling and sling/sleeve combination during sling placement. Thecross-section of the shaft 212 may have a constant shape and size, orits shape and size may vary along the length of the shaft 212. Thecross-section of the shaft 212 may assume any shape, for example,circular, semi-circular, oval, triangular or rectangular. In otherembodiments, one or more sections of the shaft 212, for example thefirst straight section 212 b may include an enlarged, flared portion todilate tissue beyond the typical diameter of the shaft 212. The shaft212 may have a tapered diameter, which may aid in dilation and tunnelingthrough tissue and in entering into lumen 206. The shaft 212 may alsohave one or more coatings, for example, to facilitate insertion of theshaft into a body of a patient or into the lumen 206.

In one illustrative embodiment, the shaft 212 is formed from a rigidmaterial, for example, a metal or a polymeric material. Examples ofsuitable metals include, but are not limited to, stainless steel,titanium, and alloys such as nitinol. Suitable polymers, which can beused as a coating on a metal to form the shaft 212, include but are notlimited to, plastics such as polytetrafluoroethylene (PTFE). In someembodiments, the shaft has some flexibility, and can be described assemi-rigid. The shaft 212 may be solid or hollow. If the shaft 212 is atleast partly hollow, it may include a lumen (not shown) with one or moreopenings along the shaft 212, for example, at the distal tip 212 e oralong the side of the shaft 212.

Although in the illustrative embodiment of FIG. 2 the shaft 212 and thehandle 210 are substantially in the same plane, in other embodiments, atleast one section of the shaft and the handle are located in differentplanes. Similarly, the shaft 212 may include sections located indifferent planes. One or more parts or the shaft 212 may assume acurved, angled, halo, helical, or any other suitable shape includingsubstantially straight.

According to the illustrative embodiment, the surface of the shaft 212is substantially smooth. However, in other illustrative embodiments, theshaft 212 may include texturing, such as stippling, to provide increasedtraction relative to a gloved hand of a medical operator. In otherembodiments, the surface of the shaft 212 may be coated with one or moredrugs such as anesthetic, anti-inflammatory, coagulating,anticoagulating, antibiotic or antimicrobial agents. The drug may bedelivered to the patient's tissue while the shaft 212 is in contact withthe tissue. The surface of the shaft may be coated with alight-absorbing coating to reduce glare, for example, under acystoscope. The coating may be a polymer, such as PTFE, or othersuitable material, such as a plastic film, and may be colored to aid indetection. The coating may aid in introduction of the shaft 212 into thebody of a patient or aid in interfitting of the shaft 212 with the lumen206 of the push tube 202. The surface of the shaft 212 may be painted sothat one can easily tell it apart from surrounding tissue and fluidunder a cystoscope to make it easier to detect under the cystoscope.

FIG. 3 shows a perspective view of the sling delivery system 200assembled as shown. The push tube 202 interfits within the lumen 106 aof the dilator tube 107 of the sling assembly 100 such that the firstend 202 a of the push tube 202 extends beyond the exterior end 107 a ofdilator tube 107 and the second end 202 b of the push tube 202 extendsbeyond the interior end 107 b of the dilator tube.

The push tube 202 is sized and shaped to slidably move through the lumen106 a of the dilator tube 107. In the illustrative embodiment, the pushtube 202 is free to advance through the dilator tube 107 in thedirection of the exterior end 107 a of the dilator tube 107 until theflared shoulder 204 of the push tube 202 abuts the interior end 107 b ofthe dilator tube 107. The diameter of the shoulder 204 is greater thanthe diameter of the lumen 106 a of the dilator tube 107, and preventsthe push tube 202 from advancing completely through the dilator tube 107in the direction of the exterior end 107 a.

The shaft 212 of delivery device 208 slidably interfits into the firstend 202 a of the lumen 206 of the push tube 202. In other embodiments,the shaft 212 may be inserted into the second end 202 b of the push tube202. In some embodiments, the push tube 202 is flexible and can bend andconform to the shape of the dilator tube 107 and/or the shape of theshaft 212 of the delivery device 208. In other embodiments, the pushtube 202 is semi-rigid or rigid. Although in FIG. 3 the shaft 212 isdepicted as being curved for a transabdominal or a transvaginalimplantation procedure, the shaft 212 may be shaped in any suitablemanner and include substantially straight, angled, halo (e.g., a curvedsection existing in substantially a single plane different than theplane of the handle), and/or helical (e.g., a curved section spiralingthrough multiple planes) portions. Other shaft shapes, such as a haloand/or helical shape, may be suitable for other implantation methods,such as a transobtural method.

FIG. 3 also depicts a second push tube 302 having all the features ofthe push tube 202. As shown, the push tube 302 slidably interfits with adilator tube 108. The push tube 302 may also have one or more curved orkinked sections 304, illustrating that the push tubes 302 and 202 may beflexible. While the push tube 302 is not shown to be associated with adelivery device, another delivery device analogous to the deliverydevice 208 may be provided for interoperating with the push tube 302.Alternatively, the single delivery device 208 may be employed with bothpush tubes 202 and 302 separately.

FIGS. 4A-F conceptually depict an illustrative method for introducing asling 102 via a transabdominal implantation approach using the slingdelivery system 200 shown in FIGS. 2 and 3. As shown in FIG. 4A,incisions 402 a and 402 b are made on each side of the midline of thebody in the lower abdomen along with an incision 404 made in the vaginalwall of the patient. The shaft 212 of delivery device 208 is insertedinto the abdominal incision 402 a to create a passage down along theposterior surface of the pubic bone through body tissue. The passage iscreated by moving the shaft 212 in from the abdominal incision 402 a andout through the vaginal incision 404 in the direction of the arrow 406.The shaft 212 is inserted until the tip 212 e and at least some of thestraight portion 212 d extend from the vaginal incision 404 out of thebody.

A shown in FIG. 4B, the first end 202 a of the push tube 202 of theassembled sling delivery system 200 of FIG. 3 is then slid over theshaft tip 212 e in the direction of the arrow 408 and advanced up theshaft 212 into the body. The push tube 202 may be advanced partiallyinto the body or completely such that the first end 202 a emerges fromthe body at the abdominal incision 402 a.

As shown FIG. 4C, the shaft 212 is then withdrawn from the body of thepatient out the abdominal incision 402 a in the direction of the arrow410. According to a further feature, withdrawal of the shaft 212 pullsthe push tube 202 by way of frictional force further into the body ofthe patient and partially out of the incision 402 a. Once the first end202 a protrudes out from incision the 402 a, it is then grasped by themedical operator and held while the delivery device 208 is pulled in thedirection of the arrow 410 to remove the shaft 212 from the lumen 206 ofthe push tube 202, leaving the push tube 202 within the body of thepatient.

As shown in FIG. 4D, the procedures described above for FIGS. 4A-C arethen repeated with the delivery device 208 and the push tube 302 on thecontralateral side of the body. With both push tubes 202 and 302inserted, a cystoscopy may be performed to verify correct placement andensure bladder integrity. Subsequent to placement verification, themedical operator grasps the push tube ends 202 a and 302 a and gentlypulls in the direction of the arrows 412 a and 412 b, respectively. Thispulls the push tubes 202 and 302 through the body from the vaginalincision 404 at least partially out the abdominal incisions 402 a and402 b, respectively. By pulling alternatively on the ends 202 a and 302a, the operator places the sling assembly 100 at the desired locationunder the urethra 999. During placement, the medical operator may referto the tab 112 to aid in positioning the sling assembly 100. Ifnecessary, the push tubes 202 and 302 and/or dilator tubes 107 and 108may be rotated one or more times to reduce twisting or other deformationthat may have occurred to the sling 102 and/or sling assembly 100.

As shown in FIGS. 4E-F, once the sling assembly 100 is suitably placed,the medical operator can cut across the middle of the tab 112, forexample, along the dotted line 414, separating sleeve portions 104 a and104 b. The tab 112 is discarded, and the operator pulls the push tubes202 and 302 in the directions of the arrows 416 a and 416 b,respectively, to slide the sleeve portions 104 a and 104 b off of thesling 102, and out of the body by way of the abdominal incisions 402 aand 402 b, leaving the sling 102 positioned in the periurethral tissuesbelow urethra 999. Although in the illustrative embodiment, the pushtubes 202 and 302 are shown to be completely out of the body prior tocutting the tab 112, in other embodiments, the sling assembly 100 andthe push tubes may be sized such that a portion of the push tube 202and/or 302 is still within the body at the time the tab 112 is cut.

FIGS. 5A-E conceptually depict an illustrative method for transvaginallyintroducing a sling 102 into the body of a patient using the slingdelivery system 200 shown in FIG. 2. As shown in FIG. 5A, incisions 502a and 502 b are made on each side of the midline of the body in thelower abdomen along with an incision 504 made in the vaginal wall of thepatient. The push tube 202 is inserted into the lumen 106 a of thedilator tube 107 of the delivery device 100. According to thisillustrative embodiment, the distal tip 212 e of the shaft 212 of thedelivery device 208 is inserted into the second end 202 b of the pushtube 202 until at least the shaft tip 212 e and at least part of thestraight portion 212 d extend beyond the first end 202 a. With the slingdelivery system 500 so assembled, the distal tip 212 e of the shaft 212is inserted into the vaginal wall incision 504 in the direction of thearrow 506 to create a passage up along the posterior surface of thepubic bone through body tissue. The passage is created by moving theshaft 212 in from the vaginal wall incision 504 and out through theabdominal wall incision 502 a. As the shaft is inserted into the body byway of the vaginal incision 504, the push tube 202 also passes into thebody. If the push tube 202 slides on the shaft 212 during insertion, theshoulder 204 may abut the handle 210. Continued insertion advances thepush tube first end 202 a out of the body through the abdominal incision502 a.

A shown in FIG. 5B, the first end 202 a of the push tube 202 is thengrasped by the medical operator and the delivery device 208 is retractedout of the body in the direction of the arrow 508. Although theillustrative embodiment of FIG. 5B depicts the second end 202 b of thepush tube 202 extending out of the body at the vaginal incision 504 atthe same time the first end 202 a is extending out the abdominalincision 502 a, this need not be the case. In some embodiments, the pushtube 202 is sized such that the second end 202 b is within the body whenthe first end 202 a protrudes from the abdominal incision 502 a.

As shown in FIG. 5C, the procedures described above for FIGS. 5A-B arethen repeated with the delivery device 208 and the push tube 302 on thecontralateral side of the body. With both the push tubes 202 and 302inserted, a cystoscopy may be performed to verify correct placement andensure bladder integrity. Subsequent to placement verification, themedical operator grasps the ends 202 a and 302 a and gently pulls in thedirection of the arrows 512 a and 512 b, respectively. This pulls thepush tubes 202 and 302 through the body from the vaginal incision 504 atleast partially out the abdominal incisions 502 a and 502 b,respectively. By pulling alternatively on the ends 202 a and 302 a, themedical operator places the sling assembly 100 at the desired locationunder the urethra 999. During placement, the medical operator may referto the tab 112 to aid in positioning the sling assembly 100. Ifnecessary, the push tubes 202 and 302 and/or dilator tubes 107 and 108may be rotated one or more times to reduce twisting or other deformationthat may have occurred to the sling 102 and/or sling assembly 100.

As shown in FIGS. 5D-E, once the sling assembly 100 is suitably placed,the medical operator can cut across the middle of the tab 112, forexample, along the dotted line 514, separating sleeve portions 104 a and104 b. The tab 112 is discarded, and the operator pulls the push tubes202 and 302 in the directions of the arrows 516 a and 516 b,respectively, to slide the sleeve portions 104 a and 104 b off of thesling 102, and out of the body by way of the abdominal incisions 502 aand 502 b, leaving the sling 102 positioned in the periurethral tissuesbelow urethra 999. Although in the illustrative embodiment, the pushtubes 202 and 302 are shown to be completely out of the body prior tocutting the tab 112, in other embodiments, the sling assembly 100 andthe push tubes may be sized such that a portion of the push tube 202and/or 302 is still within the body at the time the tab 112 is cut.

FIG. 6 shows a perspective view of an assembled sling delivery system600 according to another illustrative embodiment of the invention. Thesystem 600 includes the delivery device 208, the sling assembly 100, anda push tube 602. The push tube 602 includes a first end 602 a, a secondend 602 b, and a longitudinally extending through lumen 606, which runsthe length of the push tube between the first 602 a and second 602 bends. The push tube 602 also includes a first portion 608 having a firstoutside diameter and a second portion 610 having a second outsidediameter less than that of the first portion 608. A shoulder 604 isformed at the transition between the first and second outside diameters.

The reduced diameter portion 610 of the push tube 602 is sized andshaped to slidably move through and interfit within the lumen 106 a ofthe dilator tube 107. The portion 610 can advance through the lumen 106a in the direction of the exterior end 107 a of the dilator tube 107until the shoulder 604 abuts the dilator tube interior end 107 b. Insome instances, a segment 610 a of the reduced diameter portion 610extends beyond the exterior end 107 a of the dilator tube 107, andanother segment 610 b of the reduced diameter portion 610 extends beyondthe interior end 107 b of the dilator tube 107. The shoulder 604 issized and shaped to prohibit its passage through the lumen 106 a (shownin FIG. 1) of the dilator tube 107, i.e. the shoulder 604 has a greateroutside diameter than the inside diameter of the lumen 106 a. Theillustrative embodiment of FIG. 6 depicts only one shoulder 604.However, the push tube 602 may include more than one shoulder 604, forexample, such as described in further detail below with respect to FIG.10. Also, the push tube portions 608 and 610 may each have uniformdiameters that gradually increase or decrease one or more times, toprovide bumps, ridges, and/or grooves, for example. In otherembodiments, the two portions 608 and 610 have equal outside diameterswith the radially extending shoulder 604 having a larger diameter thaneither portion and separating the two equal diameter portions.

The lumen 606 may have a uniform diameter or may include one or morelocations of increased and/or decreased diameter. For example, the innerwalls of the push tube 602 defining the lumen 606 may include bumps,ridges, shoulders, grooves, or other internal protuberances forincreasing or decreasing the diameter of the lumen 606. As mentionedabove for the lumen 206 of the push tube 202, the lumen 606 is sized andshaped so that the shaft 212 of the delivery device 208 slidablyinterfits within the lumen 606. Depending on the sling implantationmethod, the shaft 212 may enter the lumen 606 from either the first end602 a or the second end 602 b of the push tube 602. The push tube 602may also include a tip 602 c having a taper and/or decreased outsidediameter. For example, the tip 602 c may be conical in shape.

FIG. 7 shows a perspective view of an assembled sling delivery system700 according to another illustrative embodiment of the invention. Thesystem 700 includes the delivery device 208, the sling assembly 100, andthe push tube 602. Delivery device 208 is fitted with optional pushermechanism 702. As shown in the illustrative embodiment of FIG. 7, thepush tube 602 slidably interfits with the dilator tube 107 of the slingassembly 100 as described above for FIG. 6. The reduced diameter portion610 of the push tube 602 slidably interfits within the lumen 106 a ofdilator tube 107 such that a segment 610 a extends beyond the exteriorend 107 a of the dilator tube. The shaft 212 of delivery device 208slidably interfits into lumen 606 at the second end 602 b of push tube602. A portion 212 f of the shaft 212 extends through the lumen 606 andbeyond the first end 602 a of the push tube 602.

An optional pusher mechanism 702 slidably interfits onto the shaft 212of the delivery device 208 such that the pusher mechanism can freelyslide over any portion of the shaft 212. In the illustrative embodiment,the pusher mechanism 702 interfits onto shaft the 212 prior to insertionof the shaft into the lumen 606. The pusher mechanism 702 includes agrasping area 702 a for grasping by a medical operator and a distalsurface 702 b. In the illustrative embodiment, the distal surface 702 bhas a similar or larger external diameter than the portion 608 of thepush tube 602 at second end portion 602 b so that in the course ofadvancement of the pusher mechanism 702 from the handle 210 to thedistal shaft tip 212 e the distal surface 702 b abuts the second end 602b of the push tube 602.

In other embodiments, the pusher mechanism 702 tapers in diameter, and aportion closest to the grasping area 702 a has a larger diameter thanthe distal surface 702 b or vice versa. In one such tapered embodiment,the pusher mechanism 702 tapers near the distal surface 702 b, and thedistal surface 702 b has a smaller external diameter than the internaldiameter of lumen 606. In this embodiment, the distal surface 702 b canbe wedged into the lumen 606 between the shaft 212 and the push tubewall defining the lumen 606. Such wedging may serve to dilate the lumen606 and facilitate sliding of the push tube 602 off the shaft 212.

During use of the system 700, with one hand the medical operator cangrasp the delivery device 208 by the handle 210 and with the other handgrasp the pusher mechanism 702 by the grasping area 702 a. The medicaloperator can then advance the pusher mechanism 702 away from the handle210 toward the distal shaft tip 212 e. During the advancement, thedistal surface 702 b of the pusher mechanism 702 eventually abuts thesecond end 602 b of the push tube 602. Continued advancement of thepusher mechanism 702 advances the push tube 602 into the lumen 106 a ofthe dilator tube 107 until shoulder the 604 abuts the interior end 107 bof the dilator tube. Further advancement of the pusher mechanism 702advances the push tube 602, along with the dilator tube 107, off of theshaft 212.

FIGS. 8A-D conceptually depict an illustrative method for transvaginallyintroducing a sling 102 into the body of a patient using the slingdelivery system 700 shown in FIG. 7. As shown in FIG. 8A, incisions 802a and 802 b are made on each side of the midline of the body in thelower abdomen along with an incision 804 made in the vaginal wall of thepatient. The assembled sling delivery system 700 includes the deliverydevice 208, the sling assembly 100, and the push tube 602. The shaft 212of the delivery device 208 is inserted into the vaginal wall incision804 in the direction of the arrow 806 to create a passage up along theposterior surface of the pubic bone through body tissue. The passage iscreated by moving the shaft 212 in from the vaginal wall incision 804and out through the abdominal wall incision 802 a. As the shaft 212 isinserted into the body by way of the vaginal incision 804, the push tube602 also passes into the body. If the push tube 602 slides on shaft 212during insertion, the second end 602 b may abut the distal surface 702 bof pusher mechanism 702.

As shown in FIG. 8B, the medical operator grasps the handle 210 of thedelivery device 208 and holds the device, while the other hand graspsthe grasping area 702 a of the pusher mechanism 702. The medicaloperator then slidably advances the pusher mechanism 702 distally up theshaft 212. When the distal surface 702 b abuts the second end 602 b ofthe push tube 602, continued distal advancement of the pusher mechanismpushes the push tube 602 into the body of the patient through vaginalincision 804. Advancement continues in the direction of arrow 809 untilthe first end 602 a of the push tube 602 emerges from the abdominalincision 802 a. The medical operator then grasps the first end 602 awhile the delivery device 208 is retracted in the direction of the arrow808. The shaft 212 is pulled out from the lumen 606 by way of the secondend 602 b of the push tube 602. The pusher mechanism 702 remainsassociated with the shaft 212.

As shown in FIG. 8C, the procedure described above for FIGS. 5A-B isthen repeated with the delivery device 208 and the push tube 682 on thecontralateral side of the body. With both the push tubes 602 and 682inserted, a cystoscopy may be performed to verify correct placement andensure bladder integrity. Subsequent to placement verification, themedical operator grasps the ends 602 a and 682 a and gently pulls in thedirection of the arrows 812 a and 812 b, respectively. This pulls thepush tubes 602 and 682 through the body from the vaginal incision 804and at least partially out the abdominal incisions 802 a and 802 b,respectively. By pulling alternatively on the ends 602 a and 682 a, theoperator places the sling assembly 100 at the desired location under theurethra 999. During placement, the medical operator may refer to the tab112 to aid in positioning the sling assembly 100. If necessary, the pushtubes 602 and 682 and/or dilator tubes 107 and 108 may be rotated one ormore times to reduce twisting or other deformation that may haveoccurred to the sling 102 and/or sling assembly 100.

As shown in FIGS. 8C-D, once the sling assembly 100 is suitably placed,the operator can cut across the middle of the tab 112, for example,along the dotted line 814, separating the sleeve portions 104 a and 104b. The tab 112 is discarded, and the operator pulls the push tubes 602and 682 in the directions of the arrows 812 a and 812 b, respectively,to slide the sleeve portions 104 a and 104 b off of the sling 102, andout of the body by way of the abdominal incisions 802 a and 802 b,leaving the sling 102 positioned in the periurethral tissues belowurethra 999. Although in the illustrative embodiment, the reduceddiameter portions 610 and 680 of the push tubes 602 and 682,respectively, are shown to be completely out of the body prior tocutting the tab 112, in other embodiments, the sling assembly 100 andthe push tubes may be sized such that a segment of the portion 610and/or 680 is still within the body at the time the tab 112 is cut.

FIG. 9 shows a perspective view of an assembled sling delivery system900 according to another illustrative embodiment of the invention. Thesystem 900 includes the sling assembly 100, the delivery device 208, anda push tube 902. The push tube 902 includes a first end 902 a and asecond end 902 b. The push tube 902 also includes a shoulder or flaredend 904 located at the second end 902 b where the outer diameter of thepush tube is substantially greater than that of the remaining portion ofthe push tube. The push tube 902 also includes a longitudinallyextending through lumen 906, which runs the length of the push tubebetween the first 902 a and second 902 b ends, and a window section 908where a portion of the push tube wall is absent.

Similar to push tube 202 of FIGS. 2-3, the push tube 902 is sized andshaped to slidably move through the lumen 106 a of the dilator tube 107.In the illustrative embodiment, the push tube 902 is free to advancethrough the dilator tube 107 in the direction of the exterior end 107 aof the dilator tube until the flared shoulder 904 of the push tube 902abuts the interior end 107 b of the dilator tube 107. The outer diameterof the shoulder 904 is greater than the diameter of the lumen 106 a ofthe dilator tube 107, and prevents the push tube 902 from advancingcompletely through the dilator tube 107 in the direction of the exteriorend 107 a.

In the illustrative embodiment of FIG. 9, the shaft 212 of deliverydevice 208 slidably interfits into the first end 902 a of the lumen 906of the push tube 902. In other embodiments, the shaft 212 may beinserted into the second end 902 b of the push tube 902. In theillustrative embodiment, a portion of the shaft 912 a is not within thelumen 906, while another portion 912 b is within the lumen. In someembodiments, the push tube 902 is flexible and can bend and conform tothe shape of the dilator tube 107 and/or the shape of the shaft 212 ofthe delivery device 208. In other embodiments, the push tube 902 issemi-rigid or rigid. Although in the illustrative embodiment of FIG. 9the shaft 212 is depicted as being curved for a transabdominal or atransvaginal implantation method, the shaft 212 may be shaped in anysuitable manner and include substantially straight, angled, and/orhelical portions. Other shaft shapes, such as a helical shape, may besuitable for other implantation methods, such as a transobtural method.

The push tube 902 also includes a window section 908, wherein a portionof the push tube wall that defines the lumen 906 is removed, absent, orcut out, thus exposing the lumen 906. The window section 908 is locatedintermediate to the first 902 a and the second 902 b ends. Along windowsection 908, a portion of the wall of the push tube 902 is removed todefine two sections 902 c and 902 d where the wall of the push tube isnot removed. As shown in the illustrative embodiment of FIG. 9, theportion 912 b of the shaft that is within the window section 908 isexposed. The window section 908 facilitates sliding of the shaft 212within the lumen 906 of the push tube 902 since there is less surfacearea for contact between shaft 212 and the inner walls of the push tube.

FIG. 10 shows a perspective view of an assembled sling delivery system1000 according to another illustrative embodiment of the invention. Thesystem 1000 includes the sling assembly 100, the delivery device 208,and a push tube 1002. The push tube 1002 includes a first end 1002 a anda second end 1002 b, and a longitudinally extending through lumen 1006,which runs the length of the push tube between the first 1002 a andsecond 1002 b ends. The push tube 1002 also includes two end portions1008 and 1009 located near ends the 1002 a and 1002 b, respectively.Located intermediate to the ends 1002 a and 1002 b and between the endportions 1008 and 1009 is an intermediate portion 1010, which is smallerin outer diameter than the end portions 1008 and 1009. A shoulder 1004 ais formed by the transition between the end portion 1008 and theintermediate portion 1010. Similarly, a shoulder 1004 b is formed by thetransition between the end portion 1009 and the intermediate portion1010.

The intermediate portion 1010 is sized and shaped to slidably movethrough the lumen 106 a of the dilator tube 107. The intermediateportion 1010 can advance through the lumen 106 a of the dilator tube 107in the direction of the exterior end 107 a or the interior end 107 buntil the flared shoulder 1004 b or 1004 a of the push tube abuts theinterior end 107 b or the exterior end 107 a. The outer diameters of theshoulders 1004 a and 1004 b are greater than the internal diameter ofthe lumen 106 a, and the shoulders 1004 a and 1004 b are prevented fromadvancing within the lumen. As a result, the intermediate portion 1010cannot slide completely out from the lumen 106 a of the dilator tube107, and the push tube 1002 remains slidably attached to the slingassembly 100.

As shown in the illustrative embodiment of FIG. 10, a section 1010 a ofthe intermediate portion 1010 may lie beyond the exterior end 107 a ofthe dilator tube 107, and a section 1010 b may lie beyond the interiorend 107 b. In other embodiments, the length of the intermediate portion1010 may be similar to that of dilator tube 107 such that sections 1010a and/or 1010 b are very small or even absent with respect to theoverall length of the intermediate portion 1010; such an embodiment mayleave little or no space for the intermediate portion 1010 to slidewithin the lumen 106 a.

Although in the illustrative embodiment of FIG. 10 the intermediateportion 1010 is located near the mid point of push tube 1002, in otherembodiments the intermediate portion 1010 is located near the first end1002 a or the second end 1002 b.

In the illustrative embodiment of FIG. 10, the end portions 1008 and1009 have outer diameters similar to those of shoulders 1004 a and 1004b. In other embodiments, the end portions 1008 and 1009 have smaller orlarger outer diameters than the shoulders 1004 a and 1004 b. As shown inthe illustrative embodiment, the end portions 1008 and 1009 have greaterexternal diameters than the intermediate portion 1010. However, in otherembodiments, the end portions 1008 and 1009 have similar outer diametersor smaller outer diameters than the intermediate portion 1010; in whichcase, the end portions 1008 and 1009 have smaller outer diameters thanthe shoulders 1004 a and 1004 b. Furthermore, in some embodiments, theend portions 1008 and 1009 can have similar or different outer diameterswith respect to one another.

In some embodiments, push tube 1002 is assembled by the medical operatorprior to implantation of sling 102; for example, following slidableinterfitting of the intermediate portion 1010 within lumen 106 a, one ormore end portions 1008 and/or 1009 is attached to the intermediateportion 1010, securing push tube 1002 to the sling assembly 100. Inother embodiments, the push tube 1002 is assembled during the course ofmanufacture and may be produced in association with sling assembly 100.

Unless stated otherwise herein, the various components of the inventionare made of biocompatible and/or materials, which can include, forexample, poly-alpha-hydroxy acids (e.g. polylactides, polyglycolides andtheir copolymers), polyanhydrides, polyorthoesters, segmented blockcopolymers of polyethylene glycol and polybutylene terephtalate(Polyactive™), tyrosine derivative polymers or poly(ester-amides),polyethylene/ethylene vinyl acetate (EVA) blend, polyethylene,polyester, nylon, polypropylene, thermoplastic fluorinated ethylenepropylene (FEP), TFP, stainless steel, malleable metal or anycombination of these materials. In certain embodiments, the deliveryassemblies of the invention include cadaveric, animal, and/or autologoushuman tissue

The drawings disclosed herein are not necessarily to scale; emphasisinstead is generally placed upon illustrating the principles of theinvention.

Variations, modifications, and other implementations of what isdescribed herein will occur to those of ordinary skill without departingfrom the spirit and the scope of the invention. Accordingly, theinvention is not to be limited only to the preceding illustrativedescription. For additional illustrative features that may be used withthe invention, including the embodiments described here, refer to thedocuments listed herein above and incorporated by reference in theirentirety. All operative combinations between the above describedillustrative embodiments and those features described in U.S. patentapplication Ser. No. 10/642,365, entitled “Systems, Methods and DevicesRelating to Delivery of Medical Implants,” U.S. patent application Ser.No. 10/642,365, entitled “Systems, Methods and Devices Relating toDelivery of Medical Implants,” and U.S. patent application Ser. No.10/957,926, entitled “Systems and Methods for Delivering a MedicalImplant to an Anatomical Location in a Patient,” are considered to bepotentially patentable embodiments of the invention. The contents of allreferences, patents and published patent applications cited throughoutthis Application, as well as their associated figures are herebyincorporated by reference in entirety.

Many equivalents to the specific embodiments of the invention and thespecific methods and practices associated with the systems and methodsdescribed herein exist. By way of example, in addition to being used fortranabdominal and transvaginal delivery of an implantable sling, theinvention may also be employed with a transobtural implantationprocedure. In one such procedure, a shaft of a delivery device isintroduced through an incision in the ischiopubic region and passedthrough an obturator foramen and through the vaginal wall. A push tubemay then be slid over the end of the shaft extending through the vaginalwall. The push tube may be passed along the shaft through the obturatorforamen until an end of the push tube extends through the ischiopubicincision. Alternatively, the shaft may be withdrawn sufficiently to pullthe push tube end out the ischiopubic incision. The medical operator canthen grasp the push tube and withdraw the delivery device to leave aportion of the sling assembly within the body of the patient. Theprocedure may be repeated on the contralateral side of the body with thesame or a second delivery device. The medial operator can then use thepush tubes to adjust the sling location and then remove any protectivesleeve as described above for other procedures. Removal of the pushtubes and sleeve may leave the sling ends positioned near or through therespective obturator membranes.

Accordingly, the invention is not to be limited to the embodiments,methods, and practices disclosed herein.

1. A sling delivery system comprising: an elongated shaft; a slingassembly, including an implantable sling, sized and shaped for providinga urethral platform, and first and second dilator tubes located at firstand second sling assembly ends, respectively; wherein the dilator tubesare attached to a sleeve; and first and second push tubes configured onsubstantially the same axis as the sling assembly ends and eachincluding a first end and a second end and a longitudinally extendingthrough lumen that extends from the first end to the second end of thepush tubes, wherein the longitudinally extending through lumen is sizedand shaped for slidably interfitting over the shaft; and wherein each ofthe first and second dilator tubes is sized and shaped for slidablyinterfitting over the first and the second push tubes.
 2. The system ofclaim 1, wherein the first and second push tubes include a firstradially extending shoulder for abutting an end of the dilator tubes andfor impeding passage of the push tubes through the dilator tubes.
 3. Thesystem of claim 2, wherein the first shoulder is located at an end ofthe first push tube.
 4. The system of claim 2, where the first shoulderis located intermediate between the first and second ends of the firstpush tube.
 5. The system of claim 2, wherein the first shoulder abuts aninside end of the first dilator tube, and the first push tube includes asecond radially extending shoulder for abutting an outside end of thefirst dilator tube and for trapping the first dilator tube between thefirst and second shoulders of the first push tube.
 6. The system ofclaim 1, wherein a first and a second end of the sleeve attach to thefirst and second dilator tubes, respectively.
 7. The system of claim 1,wherein the first push tube includes an intermediate section between thefirst and second ends having a window section.
 8. The system of claim 1,wherein the sling is free-floating inside the sleeve.
 9. The system ofclaim 6, wherein the first and second ends of the sleeve wrap partiallyaround the first and second dilator tubes.
 10. The system of claim 1,wherein the sleeve includes a gap exposing the entire width of thesling.
 11. The system of claim 1, wherein the sleeve covers the slingcompletely.
 12. The system of claim 1, wherein the sleeve includes alooped portion extending away from a remainder of the sleeve.
 13. Thesystem of claim 1, wherein the sleeve comprises two separate sectionswhich are fastened together.
 14. The system of claim 1, wherein thesling includes one or more tanged sections.
 15. The system of claim 1,wherein the push tubes include a tapered tip.
 16. The system of claim 1,wherein the push tubes are flexible.
 17. The system of claim 1, whereinthe shaft includes a curved portion.
 18. The system of claim 17, whereinthe shaft includes halo or helical portions.
 19. The system of claim 1,further comprising a therapeutically effective drug.
 20. The system ofclaim 1, wherein the first and second sling assembly ends comprise thesleeve.
 21. The system of claim 1, wherein the first and second slingassembly ends comprise the sling.